| CTRI Number |
CTRI/2021/11/038244 [Registered on: 25/11/2021] Trial Registered Prospectively |
| Last Modified On: |
12/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This study is to assess the effect of simple customised Yoga practice for Chronic Kidney Patients who are undergoing Hemodialysis. |
|
Scientific Title of Study
|
Effect of modified Yoga program on chronic kidney disease (CKD) Patients undergoing Hemodialysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raghunandan V |
| Designation |
PhD Scholar |
| Affiliation |
S-VYASA deemed to be University |
| Address |
Prashanti Kutiram campus: Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
v.raghunandan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apar Avinash Saoji |
| Designation |
Research Guide |
| Affiliation |
S-VYASA deemed to be University |
| Address |
S-VYASA University,
Department of Yoga and Life Science,
Prashanti Kutiram campus: Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Prashanti Kutiram campus: Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
aparsaoji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghunandan V |
| Designation |
PhD Scholar |
| Affiliation |
S-VYASA deemed to be University |
| Address |
Prashanti Kutiram campus: Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
v.raghunandan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructure support: BKF managed Dialysis Center Rangadore Memorial Hospital, Bengaluru |
| Monetory support: Self |
|
|
Primary Sponsor
|
| Name |
Raghunandan V |
| Address |
#341, 19th F main road, 1st N Block, Rajajinagar, Bengaluru, Karnataka, India |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raghunandan V |
BKF managed Dialysis Centre, Rangadore Memorial Hospital |
Dialysis Division, Room no 1,
1st Cross Road, Shankarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA |
9980072448
v.raghunandan@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC)-SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I120||Hypertensive chronic kidney disease with stage 5 chronic kidney disease or end stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Care as usual |
Standard hospital treatment, care as usual. |
| Intervention |
Modified Yoga |
1. Simple Yogic exercise
2. Yogic Breathing practice (Pranayama)
3. Yogic guided Meditation (MSRT)
Every day: 60 minutes
Total Duration: 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. CKD patients undergoing dialysis
2. CKD patients who are willing to be part of the study and sign the consent form.
3. CKD patients with age (18 - 60) years.
4. CKD patients without cardiovascular complications.
5. ESRD with CKD stage 5 patients. |
|
| ExclusionCriteria |
| Details |
1. CKD patients with cardiovascular complications.
2. Non-ESRD with CKD stage 1 to 4 patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimated Glomerular Filtration Rate (eGFR) |
Baseline
1st month
3rd month
6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Creatinine
2.Serum Electrolytes with Potassium
3.Urea
4.Hemoglobin (Hb%)
5.C-reactive protein (CRP)
6.Morphology of kidneys through abdominal Ultra sound
7.Blood Pressure (BP)
8.Heart Rate (HR)
9.Medications score |
Baseline
1st month
3rd month
6th month |
1.Pain: Visual analog scales (VAS)
2.Depression: Hamilton Depression Rating Scale (HAM-D)
3.Anxiety: Hamilton Anxiety Rating Scale (HAM-A)
4.Fatigue: Fatigue Severity Scale (FSS)
5.Symptom: Memorial Symptom Assessment Scale (MSAS)
6.Sleep Quality: Pittsburgh Sleep Quality Index (PSQI)
7.Quality of Life: WHOQOL is a quality of life assessment |
Baseline
1st month
3rd month
6th month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: CKD patients undergoing dialysis suffer not only physically, they also suffer mentally and emotionally. Evidence base studies have proved that Yoga has a positive impact on the Physical and Psychological domains.
The hypothesis of the study:
Modified Yoga program intervention on CKD patients undergoing Dialysis will be significant in 1. eGFR, Renal function test (RFT), Blood Biochemistry test, Nephrotic - Ultrasound, Blood Pressure (BP), Heart Rate (HR), and Medications score 2. Pain, Depression, Anxiety, Fatigue, Symptom, Sleep Quality and Quality of life compared to Control group.
The aim of the study: To Study the Effect of modified Yoga program on subjective and objective parameters of CKD patients undergoing Hemodialysis.
Design of the Study: The study is a randomized wait-list controlled study, the recruited participants will be divided into two groups 1. Intervention group: They will be receiving the modified yoga program as an intervention in addition to the conventional therapies (medications and hemodialysis) 2. Waitlist control group: The participants will continue to receive the conventional therapies during the intervention period. They will be offered the same yoga intervention following the follow-up period.
Intervention: The intervention group will receive modified Yoga practices for a period of 3 months and follow up to 6 months 1. Simple Yogic exercise 2. Yogic breathing practice (Pranayama) 3. Yogic guided Meditation (MSRT) Assessments: Assessments will be done at Baseline, 1st month, 3rd month, and 6th month |